510(k) K811805
- Device
- TRYPIN (125I) RIA KIT
- Applicant
- BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
- 510(k) number
- K811805
- Product code
- JNO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-08-31
- Date received
- 1981-06-24
- Regulation
- 862.1725
- Classification name
- N-benzoyl-l-arginine Ethyl Ester (u.v.), Trypsin
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 1875 Eye St. NW Suite 625 Washington DC US 20006 20006
FDA Registration Numbers#
- 8043909
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JNO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K110274 | AUTODELFIA NEONATAL IRT KIT | Wallac Oy, A Subsidiary of Perkinelmer, Inc. | 2011-06-10 |
| K102419 | GSP NEONATAL IRT KIT (3306-001U) | Wallac Oy, Subsidiary of Perkinelmer | 2010-12-16 |
| K932406 | NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KIT | Nuclear Diagnostics, Inc. | 1993-12-02 |
| K883011 | MRI NEO-TRYP TRYPSIN RIA | Microbiological Research Corp. | 1989-04-26 |
| K861097 | TRYPSIN RIA KIT | Microanalytic Research, Inc. | 1986-05-29 |
| K791202 | RIA KIT FOR TRYPSIN | Cis Radiopharmaceuticals, Inc. | 1979-11-05 |
Legacy Summary#
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FDA Review#
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